rntcp at glance

8/11/2019 RNTCP at Glance

1/20


2/20

CONTENTS

Definitions: The Revised National Tuberculosis Control Programme 1

Diagnosis 2

Staining methodKey steps in the preparation and staining of smears 3ZiehlNeelsen staining 4

Treatment 5

Expected breakup of 135 cases under RNTCP 5

Treatment categories and sputum examination schedule 6

Phases and duration of treatment 7

Duration of treatment if sputum smear is positive at 2/3 months 7

Management of patients who interrupt treatmentManagement of patients who were smear-negative at diagnosis and who 8 interrupt treatment

Management of New smear-positive cases who interrupt treatment (Category I) 9Management of retreatment smear-positive cases who interrupt 10 treatment (Category II)

Treatment of children 11Dosages for children 11How to proceed with preventive chemotherapy in children under 6 years of age 11 who were in contact with a smear-positive case

Possible side-effects of anti-tuberculosis drugs 12

Supervisory visits 13

Summary of key indicators and possible actions 1417

Reporting 18


3/20


4/20

2

DIAGNOSIS

COUGH FOR 3 WEEKS OR MORE

3 Sputum smears

3 or 2 Positives 1 Positive 3 Negatives

Antibiotics12 weeks

X-ray Symptomspersist

TB Negative for TB

X-ray

Negative for TB TB

Smear-positive TBNon-TB Smear-negative TB

Anti-TB Treatment Anti-TB Treatment


5/20

3

Step 5

Heat the slides

fromunderneathuntil vapoursrise

Stain theslides with 1%carbol fuchsin

Step 4

Place theslides in serialorder on thestaining rack

Step 3Fix the dryslide byheating briefly35 times for34 secondseach time

Step 2

Air-dry theslide for 15 30 minutes

Key steps in the preparation and staining of smears

Spreadevenly onto2/3 of centralportion of thenumberedslide

Gtwwtas

Drain off

excess water

Step 1

Break abroomstickinto two Step 7

Rinse theslides with tapwater

Dw

Step 9Rinse awayexcess stainwith tap water

Estm

Step 10

Cwm

bssStep 8 Decolourize

with 25%sulphuric acidand let itstand for 24minutes(repeat, lettingstand for 13minutes, ifnecessary)

Step 6Let the slidesstand for 5minutes

Pick up thelarge, yellowpurulentportion ofsputum

324

3 2 4


6/20

4

ZiehlNeelsen staining

1. Select a new unscratched slide and label the slide with the Laboratory Serial Number.2. Spread sputum on the slide using a broomstick.3. Allow the slide to air dry for 1530 minutes.4. Fix the slide by passing it over a flame 35 times for 34 seconds each time.5. Pour filtered carbol fuchsin to cover the entire slide.6. Gently heat the slide with carbol fuchsin on it until vapours rise. Do not boil.7. Leave carbol fuchsin on the slide for 5 minutes.8. Gently rinse the slide with tap water until all free carbol fuchsin stain is washed away.9. Pour 25% sulphuric acid onto the slide.

10. Let the slide stand for 24 minutes.11. Rinse gently with tap water. Tilt the slide to drain off the water.

12. If the slide is still red, reapply sulphuric acid for 13 minutes and rinse gently with tap water.13. Pour 0.1% methylene blue onto the slide.14. Leave methylene blue on the slide for 30 seconds.15. Rinse gently with tap water.16. Allow the slide to dry.17. Examine the slide under the microscope using x40 lens to select the suitable area and then

examine under x100 lens using a drop of immersion oil.18. Record the results in the Laboratory Form and the Laboratory Register appropriately as per

the table given below:

Examination Result Grading No. offields to beexamined

More than 10 AFB per oil immersion field Pos 3 + 20110 AFB per oil immersion field Pos 2 + 501099 AFB per 100 oil immersion fields Pos 1 + 10019 AFB per 100 oil immersion fields Scanty Record exact 200

number seenNo AFB in 100 oil immersion fields Neg 0 100

19. Store all positive and negative slides until instructed by the supervisor.20. Disinfect all contaminated material before discarding.

STAINING METHOD


7/20

5

Is the patient sputum smear-positive?*

No Yes

Does the patient have TB? Has the patient been treated for TBfor one month or more previously?

No Yes No Yes

Is the patient seriously ill?**

No Yes

No anti-TB CAT III CAT I CAT IItreatment

* Patients with extra-pulmonary TB should receive Category III treatment unless they are seriously ill, in which case theyshould recieve Category I treatment.

** Examples of seriously ill patients are those suffering from meningitis, disseminated TB, tuberculous pericarditis,peritonitis, bilateral or extensive pleurisy, spinal TB with neurological complications, smear-negative pulmonary TB withextensive parenchymal involvement, intestinal and genito-urinary TB.

TREATMENT

Expected breakup of 135 cases under RNTCP

New smear-positive : New smear-negative 50 : 50

New smear-positive (CAT I) : Retreatment smear-positive (CAT II) 50 : 25 (initially)

New smear-positive : Extra-pulmonary 50 : 10

Non-seriously ill smear-negative : Seriously ill smear-negative 40 : 10

Non-seriously ill extra-pulmonary : Seriously ill extra-pulmonary 8 : 2

Treatment Smear-positive Smear-negative Extra-pulmonary Total

Category I 50 10 (seriously ill) 2 (seriously ill) 62

Category II 25 Nil Nil 25

Category III 0 40 8 48

Total 75 50 10 135


8/20

6

Category of Type of patient Regimen Pre- Testtreatment treatment at result

sputum month is

New sputum smear-positive + 2Category I

Seriously ill sputum smear-negative

2(HRZE) 3

Seriously ill extra-pulmonary

4(HR) 3 2

Sputum smear-positive Relapse 2(HRZES) 3

Category II Sputum smear-positive Failure 1(HRZE) 3 + 3Sputum smear-posit ive Treatment 5(HRE) 3 After Default

Category IIISputum smear-negative, not 2(HRZ) 3 seriously ill 4(HR) 3 2Extra-pulmonary, not seriously ill

Start continuation phase, test sputum again at 4

+ Continue intensive phase for one more month, tagain at 3, 5 and 7 months


+ Continue intensive phase for one more month, tat 3, 5 and 7 months


+Continue intensive phase for one more month, t

at 4, 6 and 9 months


+ Re-register the patient and begin Category II tre

The number before the letters refers to the number of months of treatment. The subscript after the letters refers to the number of doses per week. H: Ison(600 mg), R: Rifampicin (450 mg), Z: Pyrazinamide (1500 mg), E: Ethambutol (1200 mg), S: Streptomycin (750 mg). Patients who weigh more than 60 kadditional rifampicin 150 mg. Patients more than 50 years old and those who weigh less than 30 kg receive streptomycin 500 mg. Patients in categories I who have a positive sputum smear at the end of the initial intensive phase receive an additional month of intensive phase treatment.

Examples of seriously ill extra-pulmonary TB cases are meningitis, disseminated TB, tuberculous pericarditis, peritonitis, bilateral or extensive pleurisy, spiwith neurological complications and intestinal and genito-urinary TB.

In rare and exceptional cases, patients who are sputum smear-negative or who have extra-pulmonary disease can have Relapse or Failure. This diagnosis insuch cases should always be made by an MO and should be supported by culture or histological evidence of current, active tuberculosis. In these cases, thpatient should be categorized as Other and given Category II treatment.

Any patient treated with Category I or Category III who has a positive smear at 5, 6 or 7 months of treatment should be considered a Failure and started Category II treatment afresh.

TREATMENT REGIMEN SPUTUM EXAMINATIONS FOR PULMONARY

IF: THEN:


9/20

7

Duration of treatment if sputum smear is positive at 2/3 months

Category Duration (number of doses) Total

Intensive phase Continuation phase

CAT I 12 weeks (36 doses) 18 weeks (54 doses) 30 weeks (90 doses)CAT II 16 weeks (48 doses) 22 weeks (66 doses) 38 weeks (114 doses)

Medication Dose Number of(thrice a week) pills in combipack

Isoniazid 600 mg 2

Rifampicin 450 mg* 1Pyrazinamide 1500 mg 3

Ethambutol 1200 mg 3

Streptomycin 0.75 g**

* Patients who weigh 60 kg ormore are given an extra 150mg dose of rifampicin

** Patients over 50 years ofage and those who weighless than 30 kg are given0.5 g of streptomycin

Phases and duration of treatment

Category Duration (number of doses) Total

Intensive phase Continuation phase

CAT I 8 weeks (24 doses) 18 weeks (54 doses) 26 weeks (78 doses)

CAT II 12 weeks (36 doses) 22 weeks (66 doses) 34 weeks (102 doses)

CAT III 8 weeks (24 doses) 18 weeks (54 doses) 26 weeks (78 doses)

MEDICATION

CAT Ipositive at 2 months CAT IIpositive at 3 months


10/20

8

Management of patients who were smear-negative at diagnosisand who interrupt treatment

Treatment Length of Do a Result Outcome Re- Treatmentreceived interruption sputum of sputum registrationbefore smear smearinterruption examination examination

Less than Less than No Resume1 month 2 months treatment

andcompleteall doses

2 months Yes Negative

or morePositive Default New

More than Less than No Resume1 month 2 months treatment

andcompleteall doses

More than Yes Negative Resume2 months treatment

and

completeall doses

Positive Default Treatment Begin CAT IIAfter treatmentDefault afresh

Begin CAT Iafresh

Resumetreatment

MANAGEMENT OF PATIENTS WHO INTERRUPT TREATMENT


11/20

9

Management of New smear-positive cases who interrupt treatment (Category I)

Treatment Length of Do a Result of Outcome Re- Treatmentreceived interruption sputum sputum registration

before smear smearinterruption examination? examination

Less than Less than No Continue CAT I*1 month 2 weeks

27 weeks No Start again onCAT I**

8 weeks Yes Positive Default New Start again onor more CAT I**

Negative Continue CAT I*

12 Less than No Continue CAT I*months 2 weeks

27 weeks Yes Positive 1 extra monthof intensivephase of CAT I


8 weeks Yes Positive Default Treatment Start onor more After CAT II**

Default


More than Less than No Continue CAT I*2 months 2 weeks

27 weeks Yes Positive Default*** Other Start onCAT II**


8 weeks Yes Positive Default Treatment Start onor more After CAT II**

Default




12/20

10

Management of retreatment smear-positive cases who interrupt treatment (Category II)

Treatment Length of Do a Result of Outcome Re- Treatment

received interruption sputum sputum registrationbefore smear smearinterruption examination? examination

Less than Less than No Continue CAT II*1 month 2 weeks

27 weeks No Start again onCAT II**

8 weeks Yes Positive Default Treatment Start again onor more After CAT II**

Default

Negative Continue CAT II*

12 Less than No Continue CAT II*months 2 weeks

27 weeks Yes Positive 1 extra monthof intensivephase of CAT II


8 weeks Yes Positive Default Treatment Start again onor more After CAT II**

Default


More than Less than No Continue CAT II*2 months 2 weeks

27 weeks Yes Positive Default** Other Start again onCAT II


8 weeks Yes Positive Default Treatment Start again onor more After CAT II

Default




13/20

11

How to proceed with preventive chemotherapy in children under 6 years of agewho were in contact with a smear-positive case

IF: AND: THEN:

The child has symptoms an MO determines a full course of anti-tuberculosisof tuberculosis (preferably in treatment (CAT III) should be given.

consultation with apaediatrician) that thechild has tuberculosis

The child does not a tuberculin test is the child should receive preventivehave symptoms of not available chemotherapy for 6 monthstuberculosis (isoniazid daily5 mg per kg body

weight).

a tuberculin test is the child should receive 3 monthsavailable of INH preventive chemotherapy and

a tuberculin test should then be done.

IF: THEN:The childs stop the preventiveinduration to the chemotherapy andtuberculin test give BCGis less than vaccination (if6 millimetres not previouslyin diameter vaccinated).

The childs continue isoniazidinduration preventive chemo-to the tuberculin therapy for anothertest is 6 3 months.millimetres ormore in diameter

Dosages for children

Drugs Therapy per dose(thrice a week)

Isoniazid 1015 mg/kgRifampicin 10 mg/kg

Pyrazinamide 35 mg/kg

Streptomycin 15 mg/kg

Ethambutol* 30 mg/kg

* Should not be given to children below 6years of age

TREATMENT OF CHILDREN


14/20

12

Symptom Drug (abbreviation) Action to be taken

Drowsiness Isoniazid (H) Reassure patient

Redorange urine/tears Rifampicin (R) Reassure patient

Gastrointestinal upset Any oral medication Reassure patientGive drugs with less waterGive drugs over a longer

period of time (e.g. 20 minutes)Do not give drugs on empty

stomachIf the above fails, give anti-

emetic if appropriate

Burning in the hands Isoniazid (H) Give pyridoxine 100 mg/dayand feet until symptoms subside

Joint pains Pyrazinamide (Z) If severe, refer patient for evaluation

Impaired vision Ethambutol (E) STOP ethambutol, refer patient for evaluation

Ringing in the ears Streptomycin (S) STOP streptomycin, refer patient for evaluation

Loss of hearing Streptomycin (S) STOP streptomycin, refer patient for evaluation

Dizziness and loss of Streptomycin (S) STOP streptomycin, referbalance patient for evaluation

Jaundice Isoniazid (H) STOP treatment, refer patientRifampicin (R) for evaluationPyrazinamide (Z)

In all cases of jaundice, anti-tuberculosisdrugs should be stopped immediately

and the patient referred for evaluation.

POSSIBLE SIDE-EFFECTS OF ANTI-TUBERCULOSIS DRUGS


15/20

13

Category of Methodology of supervision Number of supervisory visitssupervisor

DTO/MO (DTC) Interview the MO-TC, MO I/C of To visit all TUs every month, allPHC-CHC, STS, STLS and the CHCs and Block PHCs in the districtperson incharge of anti-TB drug every quarter, one sub-centre fromstorage. each Block PHC area and a proportionRandom interview of patients of tribal sub-centres every quarter.and community leaders.Inspection of records of the TU,PHC and CHC, and stock ofanti-TB drugs and laboratoryconsumables.Random checking of themicroscopy centre and sub-centre.

MO-TC Interview the MO I/C BPHC/CHC/ To visit at least once every(Tuberculosis PHC. Random interview of quarter all CHCs/BPHCs/ Unit) patients and community leaders. PHCs, microscopy centres, and a

Random checking of the proportion of sub-centres.microscopy centre and sub-centre stock of anti-tuberculosisdrugs and laboratory consumables.

STS Interview MPHS and MPWs at To visit all PHCs and CHCs everythe PHC sub-centre. Inspect month and all sub-centres everyrecords, Tuberculosis Treatment quarter.Cards and Tuberculosis Laboratory

Register.Random interview of patients.

STLS Inspect all microscopy centres To visit all microscopy centres in theand laboratory records. jurisdiction of the TU at least

once a month.

SUPERVISORY VISITS


16/20

15

Quarterly Report Indicator Possible Actions

New and retreatment cases

Expected:New smear-positive Calculated annualized Ensure that chest symptomatics in all facilities undergo sputum smear examination (at least 2% adultcases: 4085/100 0 00 incidence of New outpatients).

smear-positive cases isless than 40/100 000 Ensure that three sputum smear examinations are being done on all chest symptomatics.

Ensure that sputum smear microscopy is being done correctly (5%15% positivity among patientsexamined for diagnosis). Intensify review of slides read as smear-negative, particularly those of patientsplaced on treatment.

Ensure that all smear-positives in the Laboratory Register are recorded in the Tuberculosis Register.Ensure that sputum smear microscopy is accessible to patients throughout the assigned area, with trainedlaboratory technicians in place.

Calculated annualized Ensure that active case-finding is not being done in any area.incidence of Newsmear-positive cases is Ensure that sputum smear microscopy is accurate. Ensure review of slides of smear-positive patients.more than 85/100 000

Ensure that only patients who reside in the area are being treated.

Expected:Retreatment smear- Retreatment cases Ensure that accurate history-taking is being done at all levels. Patients must be questioned carefullypositive cases are 50% are less than 40% about prior treatment for tuberculosis from any source. It should be explained to patients that only ifof New smear-positive of New smear-positive they provide accurate information can the most effective treatment be given.cases in initial years of casesRNTCP im ple me nt at ion Make su re th at def init io ns are be ing app lied co rrect ly. An y sm ea r-p osi tive pat ien t tre at ed in the pa st for

more than one month and has defaulted for more than two months, should receive the retreatment(CAT II) regimen.

Retreatment cases are Ensure that active case-finding is not occurring. With active case-finding, many old TB cases are reported.more than 70% of Newsmear-positive cases Ensure that history-taking is accurate and definitions are being correctly applied.

Ensure that new symptomatic patients undergo three sputum smear examinations for acid-fast bacilli (AFB).Expected:At least 50% of all New Among New pulmonary Ensure that over-diagnosis of sputum smear-negative patients is not occurring on account of over-pulmonary cases will be cases, proportion which reliance on radiography. No patient should begin treatment without having three sputum smearsmear-positive are smear-positive is examinations done.

less than 40%Ensure that three sputum smear examinations are being done on all chest symptomatics.

Ensure that sputum smear microscopy is being done correctly. Consider review of slides of smear-negative patients placed on treatment.

SUMMARY OF KEY INDICATORS AND POSSIBLE ACTIONS


17/20

14

Expected:No more than 20% of The proportion of Ensure that only seriously ill patients are given CAT I treatment. Non-seriously ill smear-negativesmea r-ne ga tive / sm ea r-n eg at ive or New pat ien ts sho ul d re cei ve CAT II I tre at men t.extra-pulmonary extra-pulmonarypatients are considered seriously ill patients Ensure that sputum microscopy is being done correctly. Consider review of slides of smear-negativeseriously ill and placed included in CAT I is patients placed on treatment.under CAT I greater than 25%

Conversion

Expected:Conversion rate is 90% Less than 85% of Ensure that Medical Officers, treatment supervisors, and all staff in the programme and at peripheral

smear-positive CAT I centres understand the importance of follow-up sputum examinations. Follow-up sputum examinationspatients are are the best measure of patient response to treatment. Results of sputum examinations change patientdocumented t reatment and a re c ri ti ca l t o p rogramme eva luat ion.to become sputumsmear-negative at 3 Visit all centres with low rates of sputum conversion and resolve any problems with the help of themonths staff.

Make sure defaulter rates in the first two months are


18/20

17


Quarterly Report Indicator Possible ActionsTreatment outcome

Expected:Cure rate is 85% or more Cure rate of Visit centres with low cure rates to discuss with patients and staff the reasons and possible

smear-positive patients solutions. Make sure that each centre is aware of its cure rate so that it can take steps tois less th an 80% imp rove perf orma nce .

Ensure that accurate history-taking is being done at all levels. Patients must be questioned carefullyabout prior treatment for tuberculosis from any source. It should be explained to patients that only if theyprovide accurate information can the most effective treatment be given. If previously treated patients arenot given the retreatment regimen, they may not respond well to treatment.

Make sure that definitions are being applied correctly. Any smear-positive patient treated for more than onemonth in the past, with default of more than two months, should receive the retreatment (CAT II) regimen.

Ensure that every dose of medication is observed during the intensive phase of treatment, and at leastone dose per week in the continuation phase. Ensure return of empty blister packs during weeklycollection of drugs. Observation sites should be convenient for the patient.

Ensure that health workers are dispensing medication properly as per technical guidelines.

Ensure that follow-up sputum smear examinations are being done according to guidelines.

Cure rate of smear- Check to make sure the report is correct. If it is, consider checking to make sure that reporting andpositive CAT I patients classification of treatment outcomes is being done correctly and that all detected smear-positive patientsis m ore t ha n 9 5% a re reg iste red .

Expected:No more than 3% of Per cent of New smear- Ensure that follow-up sputum examinations are being done as per policy. Carefully track this at all Newsmear-positive positive patients who treatment units.patients are given the are classified as havingtreatment outcome completed treatment is Explain to Medical Officers and others the crucial importance of the follow-up sputum examinations.complete more than 5%

Locate patients who have recently completed treatment and obtain sputum samples for examination.

Carefully review all data on patients to ensure accuracy of information and to ensure that treatment isbeing given under direct observation as per policy.

Expected:No more than 4% New Per cent of New smear- Ensure that every dose of medication is observed during the intensive phase of treatment, and at leastsmear-positive patients positive patiens who one dose per week in the continuation phase. Observation sites should be convenient to the patient.die during treatment die during treatment is

more than 5% Review information on patients who died to determine the reasons.

If patients are presenting for treatment when already moribund, consider ways and means to encourangemore prompt referral and diagnosis so that patients can be treated earlier in the course of their TBillness.

If all of the above has been done and death rate is still more than 5%, consider evaluation of theprevalence of HIV infection among TB patients, to be done strictly as per policy with safeguards ofconfidentiality.


19/20

16

Quarterly Report Indicator Possible ActionsTreatment outcome

Expected:Failure: No more than 4% Per cent of New Ensure that accurate history-taking is being done at all levels. Patients must be questioned carefullyof New smear-positive smear-positive patients about prior treatment for tuberculosis from any source. It should be explained to patients that only ifpatients are smear-positive who fail treatment is they provide accurate information can the most effective treatment be given. If previously treated5 or more months after more than 5% patients are not given the retreatment regimen, they may not respond well to treatment.the start of treatment

Make sure that definitions are being applied correctly. Any smear-positive patient treated for more thanone month in the past, with default of more than two months, should receive the retreatment (CAT II)regimen.

Ensure that every dose of medication is observed during the intensive phase of treatment, and at least

one dose per week in the continuation phase. Ensure return of empty blister packs during weeklycollection of drugs. Observation sites should be convenient for the patient.

Ensure that health workers are dispensing medication properly as per technical guidelines.

Ensure that drugs are of acceptable quality, that drugs are stored in appropriate conditions, and thatthey are being used before their expiry period.

If all of the above has been done and failure rate remains higher than 5%, consider evaluation of thelevel of primary drug resistance in the community.

Expected:Default rate is less than Default rate of smear- Visit centres which have the highest default rates and interview staff and patients to determine the5% positive CAT I efforts made to retrieve patients, the reasons for default and possible solutions. Make sure that centres

patients is more are aware of their default rate so they can take steps to reduce it.than 10%

Ensure that patient history is being carefully ascertained, including the address. A visit to patientshomes should be made to verify addresses, and landmarks near the house should be recorded in theTreatment Card. To the greatest extent possible, services should be convenient to the patient in termsof distance, time and staff attitudes.

During the visit to the house for verification of address, note the name and address of a person who

can be contacted in the event the patient defaults.

Ensure that directly observed treatment is being given to patients in the intensive phase and at leastone dose per week is being directly observed during the continuation phase.

Ensure that each centre is aware of its own default rate so that it can take steps to improveperformance.

Expected: Percentage of patients Transfer out can be a way of disguising default. Patients should only be categorized as TransferredTransferred out is who fall under outcome out if they have been given a Transfer Form to bring to the jurisdiction to which they are beingles s than 3% category Trans fe rred t rans fe rred . Ensure tha t counter fo il s have been r eceived.

out is more than 5%



20/20

18

Due dates for reports from Tuberculosis Units to DTC

Due On Quarterly Report Period Covered

7 January 2000 New and Retreatment Cases 1 October31 December 1999Programme Management 1 October31 December 1999Sputum Conversion Cohort 1 July30 Setember 1999Treatment Outcome Cohort 1 October31 December 1998

7 April 2000 New and Retreatment Cases 1 January31 March 2000Programme Management 1 January31 March 2000Sputum Conversion Cohort 1 October31 December 1999Treatment Outcome Cohort 1 January31 March 1999

7 July 2000 New and Retreatment Cases 1 April30 June 2000Programme Management 1 April30 June 2000Sputum Conversion Cohort 1 January31 March 2000Treatment Outcome Cohort 1 April30 June 1999

7 October 2000 New and Retreatment Cases 1 July30 September 2000Programme Management 1 July30 September 2000Sputum Conversion Cohort 1 April30 June 2000Treatment Outcome Cohort 1 July30 September 1999

7 January 2001 New and Retreatment Cases 1 October31 December 2000Programme Management 1 October31 December 2000Sputum Conversion Cohort 1 July30 September 2000Treatment Outcome Cohort 1 October31 December 1999




7 January 2002 New and Retreatment Cases 1 October31 December 2001Programme Management 1 October31 December 2001Sputum Conversion Cohort 1 July30 September 2001Treatment Outcome Cohort 1 October31 December 2000




The District TB Officer is to retain one copy for records and send the quarterly reports to the StateTB Officer, The National Tuberculosis Institute (Avalon 8, Bellary Road, Bangalore 560 003), and

the Central TB Division (Nirman Bhavan, Directorate General of Health Services, Ministry of Healthand Family Welfare, New Delhi 110 011). All reports to reach Central TB Division by the 24th of themonth.

REPORTING

rntcp at glance

Documents